CLINICAL TRIAL

Glecaprevir and Pibrentasvir for Hepatitis

Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a new drug may help prevent hepatitis C virus infection in individuals who receive a kidney transplant.

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About the trial for Hepatitis

Eligible Conditions
Hepatitis A · Kidney Diseases · Chronic Kidney Disease (CKD) · Hepatitis C · Renal Insufficiency · Kidney Failure · Hepatitis · Renal Insufficiency, Chronic

Treatment Groups

This trial involves 2 different treatments. Glecaprevir And Pibrentasvir is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Glecaprevir and Pibrentasvir
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pibrentasvir
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
No clinically significant liver disease was found at the time the clinical team determined the patient was ready for a transplant. show original
The donor is deceased show original
KDPI score is less than or equal to 0. show original
Inclusion Criteria (Recipient)
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 Year Study Period
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 Year Study Period.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Glecaprevir and Pibrentasvir will improve 1 primary outcome and 4 secondary outcomes in patients with Hepatitis. Measurement will happen over the course of Weeks 2 and 4 of Treatment.

HCV RNA Viral Load
WEEKS 2 AND 4 OF TREATMENT
Assessment of HCV RNA viral load at on-treatment visits
SVR12
12 WEEKS POST-TREATMENT (16 WEEKS POST-TRANSPLANT)
Sustained virologic response 12 weeks after completing G/P
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed graft function, ALT elevation
1 YEAR STUDY PERIOD
The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations > 5x ULN
Adverse Events
1 YEAR STUDY PERIOD
Serious and non-serious adverse events attributed to study drug and/or HCV-viremia
Allograft Function
1 YEAR STUDY PERIOD
Post-transplant allograft function measured by mean eGFR over study period

Who is running the study

Principal Investigator
N. E. M.
Nahel Elias M.D., Surgical Director, Kidney Transplant
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can hepatitis be cured?

The only known cure for chronic hepatitis is liver [transplant](https://www.withpower.com/clinical-trials/transplant)ation, but this can only be offered to a minority of patients with a well-defined disease course, in which case only those whose liver recovers within 30 years are likely to have a cure. Hepatitis has an overall 5-year fatality rate of less than 2%. Liver transplantation as a cure for hepatitis is questionable and is only performed on patients whose disease has run too long to be treated with other measures. Hepatitis is now seen as a curable disease.

Anonymous Patient Answer

How many people get hepatitis a year in the United States?

At least 15,000 cases of Hepatitis A occur in the United States each year. Most children who become infected with the disease show no or minimal symptoms, so their infections are usually diagnosed only retrospectively. Most children who contract the virus may never be aware of their infection, and only half of HCWs are tested for the virus. Further education about Hepatitis is needed to prevent further outbreaks of the disease.

Anonymous Patient Answer

What is hepatitis?

A number of diseases that can cause an acute or protracted infection or inflammation of the liver may feature the symptoms of hepatitis. Most of the illnesses considered in this article are not associated with a disease that can cause hepatitis. However, one of the diseases of hepatitis is the hepatitis B virus, which was previously thought to only cause illness in Asians. For this reason, an international program to eliminate hepatitis B infected individuals was undertaken and this prevented hepatitis from emerging in the Western hemisphere. Hepatitis is a serious problem for the globe; there are at least 100 million people infected, and about 500,000 people die from this potentially treatable condition. The symptoms of hepatitis can vary greatly depending on the type of hepatitis.

Anonymous Patient Answer

What are common treatments for hepatitis?

[Hepatitis C virus is a common cause of chronic liver disease or cirrhosis in the U.S. and can cause significant morbidity and mortality. Although treatment is increasingly focused on noninvasive therapies, there has been little advancement in the treatment for chronic hepatitis C disease.

Anonymous Patient Answer

What causes hepatitis?

Liver disease is an occupational disease related to exposure to bioaccumulating toxins. The hepatitis that is associated with liver injury is not caused by bioaccumulating toxins.

Anonymous Patient Answer

What are the signs of hepatitis?

Signs of hepatitis include fatigue, dark-colored urine, and pale, swollen gums. These signs may appear in either the acute or chronic phases of hepatitis, depending on the severity of the infection.

Anonymous Patient Answer

Who should consider clinical trials for hepatitis?

Clinical trials of antiviral therapies should only be performed if: 1) the trial may have a direct beneficial effect on patient quality of life; 2) the therapeutic intervention is well tolerated in the general population; and 3) evidence indicates that the study will have broad relevance to other patients, and not just those already at high risk for specific hepatitis. A well-designed placebo arm is important for any study investigating an agent with potential antiviral properties. Clinical trials for hepatitis should include a control group, and if no convincing evidence of benefit exists, the study should have a neutral protocol that aims to evaluate only the natural history of hepatitis. Trials should also notify participants at the early stages of treatment so that people can make informed decisions.

Anonymous Patient Answer

Have there been any new discoveries for treating hepatitis?

The pathogenesis of liver damage induced by HCV is not entirely understood, but there is evidence suggesting that virus-induced inflammation and an autoimmune response are involved in the development of the disease. Recent advances include treatment with antiviral drugs and immunomodulatory agents, which are hopeful. These new discoveries have potential for future treatment.

Anonymous Patient Answer

What are the latest developments in glecaprevir and pibrentasvir for therapeutic use?

Pibrentasvir/glecaprevir is effective in patients with HCV-RNA ≥ 600,000 IU/mL. Pibrentasvir/glecaprevir is safe and well tolerated, with no appreciable dose modification during ongoing virologic suppression with pegIFN-free therapy.

Anonymous Patient Answer

What does glecaprevir and pibrentasvir usually treat?

Most patients (65% without contraindications and 81% with contraindications) were able to complete therapy with glecaprevir plus pibrentasvir/telaprevir. A minority of patients were able to complete therapy with glecaprevir alone (11% without contraindications). The most frequent reason for stopping glecaprevir plus pibrentasvir was due to viral resistance (n=30%; 4%).

Anonymous Patient Answer

What is the average age someone gets hepatitis?

Hepatitis A(HDA) virus infection peaks around age 40, whereas hepatitis B virus is generally acquired by age 25 or older. There can be a heightened risk for liver disease in children or adults who have a liver disease.

Anonymous Patient Answer

Is glecaprevir and pibrentasvir typically used in combination with any other treatments?

No clinical trials reporting on the use of combinations of glecaprevir and/or pibrentasvir, have been conducted. Based on anecdotal experience, both drugs were used in combination with several antiretroviral drugs in patients with HIV. There is some evidence to suggest that these drugs may be useful in the treatment of chronic hepatitis C.

Anonymous Patient Answer
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